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[Improving Solubility Spotlight] Hot Melt Extrusion Challenges and Solutions

Speakers:

Hibreniguss Terefe, Ph.D (Vice President, Research & Development, ExxPharma Therapeutics LLC)

Anna VanDyke (Senior Sales Manager, AbbVie)

Traciann Scirbona (Process Engineer, Hovione LLC)

Date: Tuesday, April 24

Time: 3:00pm - 3:45pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Development

Vault Recording: TBD

Part I
Hot Melt Extrusion (HME) technology is gaining popularity in the manufacture of Amorphous Solid Dispersion (ASD) based solubility enhanced drug products. Thorough understanding about the drug substance, formulation and HME process parameters is key to success in the development of ASD based drug products that fulfill all Critical Quality Attributes. Application of QbD at early development stage facilitates early risk assessment and helps develop formulations and processes that incorporate risk mitigating measures.

During this presentation, our speaker will:

  • Explore the successful application of HME in developing solubility enhanced products
  • Provide examples of drug substance physicochemical properties (such as high melting point, high propensity to crystallization, prone to degradation) that pose formulation and process challenges in the application of HME.
  • Offer potential solutions that overcome challenges